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May 19 — Generic drug makers asked the U.S. Supreme Court May 17 to reverse a decision limiting
their “safe harbor”
under the Hatch-Waxman Act.

The safe harbor is typically used by generic firms that perform some acts, prior to
market introduction, that would infringe a brand drug maker's patent. Brand and generic
makers have been battling over its limits for the past eight years, resulting in a
split U.S. Court of Appeals for the Federal Circuit on the topic, particularly as
related to activities after approval by the Food and Drug Administration.

But this case has a couple of twists, including that all the combatants are generic
firms making the no-longer-patented anticoagulant Lovenox (enoxaparin sodium injection).
Amphastar Pharmaceuticals Inc., International Medication Systems Ltd. and Actavis
Inc., formerly Watson Pharmaceuticals Inc., are accusing Momenta Pharmaceuticals Inc.
of “hijacking” the only approved test for showing bioequivalence by getting a process
patent on it.

Bioequivalence must be shown to the FDA on an ongoing basis, well after FDA approval
and market introduction.

The three firms'petition cites the growing number of Hatch-Waxman cases involving biosimilar generics, which
will have similar testing requirements, as a reason for the court to define the breadth
of the safe harbor now.

Post-Approval Yes, ‘Routine'
Reporting No

The petitioners charge the Federal Circuit with continually trying to read limits
into the safe harbor that aren't in the statute.

Early on, the Federal Circuit was conflicted on whether the safe harbor covered any
activities conducted after FDA approval. In fact, the court has now ruled twice on
this case; its first ruling appeased the government's concerns, which appeased the
Supreme Court's concerns.

Faced with a related petition in another case, the high court asked for the views
of the government. But the Office of the Solicitor General recommended against review
then, saying that the Momenta decision had resolved the court's internal conflict properly (06 PTD, 1/9/13).

The case came back to the Federal Circuit, leading to the decision at issue here.
Moore switched sides, joining Judge Evan J. Wallach's opinion in favor of Momenta,
with Dyk in dissent.

Amphastar contends that the word “routine” is nowhere in the statutory text and is
against the intent of the Hatch-Waxman Act. Legislation intended to bring generic
drugs to market is circumvented if Momenta can “monopolize the generic market for
a drug,” the petition said.

The alleged infringers are unlikely to find support from the government this time
around, though. The U.S. attorney general weighed in with an amicus brief in this second appeal, and its brief was arguably the genesis for the court's use
of the word “routine.”

Side Issues Not in Question Presented

Two other points may affect the Supreme Court's decision on whether to grant review.

The Federal Circuit also held that Teva Pharmaceuticals USA Inc. could take advantage
of the safe harbor by importing generic enoxaparin; because its testing was not performed
in the U.S., it could not infringe a U.S. patent. That appears to favor overseas manufacture
of generic drugs.

Second, the test requirement here is set by the United States Pharmacopeia (USP) Convention,
a kind of standards-setting body. The petitioners contend that Momenta participated
in the committee that selected the test and “never disclosed to USP its then-pending
patent application.”

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